In 2002 approximately 6.6 million people in the United States underwent cosmetic procedures (both surgical and non-surgical). Of this, a number of procedures were non-surgical injections for the removal of wrinkles and various other aesthetic defects. The market for aesthetic injectables is extremely large and has grown quite quickly over the past 5 years, increasing 26% from 2003 to 2004. The injectables market is now over $2.19 billion with BOTOX® as the leader with 81% percent of all sales. These injections are comprised of various materials including Botulinum toxin (i.e., BOTOX®) and a class of materials known as facial fillers.
Facial fillers are materials that are biologically inert. They are injected subdermally into the area of concern and fill the area, thus removing unwanted facial wrinkles and other cosmetic defects. The most common fillers, and Botulinum toxin, are noted below with potential drawbacks.
In one procedure, autologous fat is removed via a mini liposuction procedure from other parts of the body such as the thighs, buttocks or stomach, and is used to fill wrinkles and contour lines. There is no concern of allergic reactions, but this is a multi-step process that is more invasive, and is more costly due to additional time in the doctor's office.
Botulinum toxin is a bacterial toxin. Serious heart problems and serious allergic reactions have been reported with its use. These symptoms include difficulty swallowing, speaking or breathing. The most common side effects following injection include temporary eyelid droop and nausea. Localized pain, infection, inflammation, tenderness, swelling, redness, and/or bleeding/bruising have also been noted.
Bovine collagen is a tissue-extracted dermal filler material that is costly and has both viral clearance issues as well as BSE (Mad Cow Disease) concerns. Allergic reactions have also been reported and thus skin tests are required.
Calcium hydroxyapatite is a common component of Bone Filler, a thick pasty material that is difficult to inject. It is typically used in conjunction with other injections and is not FDA approved, but instead is an “off-label” use.
Human collagen is more costly than Bovine collagen and difficult to obtain. No allergic reactions have been noted, but extensive testing for HIV and other viruses must be performed.
Hyaluronic acid (HA) is made from a basic element in connective skin tissue, HA gel, along with collagen, is the framework or medium that skin cells live in. Results of its use as a dermal filler indicate that it appears to last longer than collagen and human fat. The drawbacks are that HA comes from one of two sources, avian (bird) tissues extraction, and the bacteria Streptococcus pneumoniae (a human pathogen that is the chief cause of pneumonia). Allergic reactions have been noted and skin tests are required.